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NCT00090051 · ClinicalTrials.gov registry record · Phase 3
FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 552
- Enrollment target
NCT00090051: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00090051 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 552 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00090051, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 552 participants
- Enrollment target
Study Summary
The purpose of this study is to provide treatment for patients who have chronic lymphocytic leukemia (CLL), and to compare the use of rituximab added to fludarabine+cyclophosphamide (FC) with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms.
Primary Outcome
Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause, whichever came first. Patients without a PFS event were censored at their last tumor assessment date.
Interventions
- DRUG Cyclophosphamide
- DRUG Rituximab
- DRUG Fludarabine Phosphate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 552 participants |
| Start Date | 2003-07-31 |
| Est. Completion | 2012-05-31 |
| Phase | Phase 3 |
What the finished NCT00090051 record still lists
NCT00090051 is an interventional study that assigns participants to a tested intervention. The registered 552 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT00090051 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00090051 about?
NCT00090051 is a clinical study titled "FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients". The purpose of this study is to provide treatment for patients who have chronic lymphocytic leukemia (CLL), and to compare the use of rituximab added to fludarabine+cyclophosphamide (FC) with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms.
What is the current status of trial NCT00090051?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 552 participants. The study started on 2003-07-31. Estimated completion is 2012-05-31.
What interventions are being tested in trial NCT00090051?
The interventions under investigation include: Cyclophosphamide (DRUG), Rituximab (DRUG), Fludarabine Phosphate (DRUG).
Who is sponsoring clinical trial NCT00090051?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00090051's enrollment target sits among peer trials
552 678th of 2000 higher than 1,321 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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